Automated Medication Adherence System

ABSTRACT

An automated medication adherence system. The automated medication adherence system may comprise: a housing, an electronic interface, a plurality of reservoirs, one or more sensors, and at least one pill delivery and lock-out module. The electronic interface is programmable to accept data relating to a medication, including at least one of a pill identify, a user identity, a dosage schedule, and a side effect. The electronic interface actuates rotation of a reservoir, which is configured to receive, store, and dispense pills, tablets, and capsules of various sizes accurately and precisely. The sensors monitor medication input and output, and alerts a user when medication has been dispensed and needs to be taken.

FIELD OF USE

The present disclosure relates generally to the field of articledispensing, and more specifically, to an automated medication adherencesystem for use in user's home.

BACKGROUND

In 2010, there were 15.4 million Medicare beneficiaries over the age of65 with four or more chronic conditions, of which 43% were hospitalizedat least once during the year. Further, an estimated 39% of the elderlypopulation has some type of disability (i.e., difficulty in hearing,vision, cognition, ambulation, self-care, or independent living). For aconsiderable number of individuals, these types of disabilities may makeit difficult to adhere to a medication schedule.

Many of these individuals may depend on untrained volunteers, family, orfriends to help them manage their medications. Current estimates statethere are 34.2 million Americans that have provided unpaid care to anadult 50 years old or over. Approximately a quarter of these caregiversprovide 41 or more hours of care per week, typically for a closerelative who has been hospitalized in the past year. These caregiversoften experience stress, physical and financial strain, and adverseimpacts on their health while they perform complex medical and nursingresponsibilities.

Furthermore, the U.S. Census Bureau anticipates population growth of 60%for the age group over 65 years old and a population decline of 1% inthe age group 45 to 64 years old between 2014 and 2030. This majordemographic shift may significantly affect the support system for theelderly. Even individuals that receive assistance from a paid homehealth aide may still have issues managing their medications, as themajority of home health aides do not administer medication or provideassistance with self-administration of medications. Many of these homehealth aides are prohibited to administer medication by state law, orhave not obtained the required medication technician certificationrequired by most nurse delegation programs due to cost and potentialliability concerns.

Even though the elderly currently comprise only 12% of the population,they consume 33% of all prescription drugs with two out of five Medicarebeneficiaries taking five or more prescription medications. The largenumber of medications prescribed to the elderly and chronically ill,combined with the cognitive and sometimes physical challenges offollowing multiple medication regimens, reduce a patient's ability tofully benefit from prescribed medications. It has been estimated that20-30% of medication prescriptions are never filled and 50% of the timemedication is not continued and completed as prescribed. Polypharmacy,defined as taking multiple medications concurrently to treat coexistingdiseases, with the elderly typically leads to medication non-adherenceand is estimated to occur among 25%-75% of elderly patients, with therate of occurrence increasing in proportion to the number of drugs anddaily dosages prescribed. Lack of medication adherence can result indisease progression, death and higher costs to the healthcare system.Furthermore, non-adherence was estimated to account for 10% of hospitaladmissions and 23% of nursing home admissions. The New EnglandHealthcare Institute calculates non-adherence along with suboptimalprescribing, drug administration and diagnosis could result in up to$290 billion in losses annually in the US. Additionally, estimatesreport the effect of poor medication adherence results in approximately125,000 deaths in the US annually.

There are a growing number of studies that have documented net savingsassociated with higher medication adherence across a range of commonchronic conditions. One study demonstrated improved medication adherencemight provide a net economic return for certain chronic conditions,including diabetes, hypertension, hypercholesterolemia and congestiveheart failure. Consequently, the study noted increased adherence to drugtherapy reduced a patient's need for medical services, includinghospitalizations and emergency room visits.

However, independent management of drug administration is a relativelyineffective way to increase medication adherence. Seven-day pillboxesare probably the most common products used, but they require manualsorting of pills on a weekly basis. This is an unreliable and cumbersomeprocess that sometimes requires assistance from a caregiver orpharmacist. One study noted that the majority of elderly patients may beunable to open and access their medications from multi-compartmentpillboxes with ease, and cognitively impaired patients may experienceeven more difficulties than others. Forgetfulness is a major factorcontributing to non-adherence, with an estimated 30% of patients withchronic conditions asserting forgetfulness. This poses a furtherchallenge to independent seniors, which are at a higher risk offorgetting to take their medication if they experience increasedbusyness. However, most pillboxes do not provide interactive remindersor instructions, and are thus inadequate solutions in this respect.Another downside to pillboxes is that they may promotecross-contamination, as different pills are placed inside a smallcompartment together.

Smart phone applications have been developed to assist in medicationadherence through reminders and alerts, but are not comprehensivesolutions addressing the specific needs for patients with severalchronic conditions and potentially suffering from physical and cognitiveimpairments. As a result, reminders and alarms alone are not likely toimprove adherence unless they are designed to provide relevantinformation with interactive features to facilitate addressing theseconcerns on a timely basis. Lastly, there are mail order pharmacies thatspecialize in pre-sorting prescription pills into pill pouches orblister packs and shipping directly to patients. However, the process ofmanaging medication changes is cumbersome and apt to wasting a supply ofmedication. Although the pre-sorted packets help to simplify themedication administration, this is clearly not an interactive systemwith real-time capability to remind, instruct, monitor, and alert thestatus of the patient's medication adherence record.

Currently, there are no medication adherence solutions on the marketthat are comprehensive, fully automated, and requires no programming bythe user. In addition, critical information such as medicationformularies, e-prescriptions and pharmaceutical databases are kept in“silos” and are not readily available in an integrated fashion, makingit difficult to retrieve data for contextual analysis. Consequently,even the more advanced medication administration products on the marketstill require manual pill sorting and programming of alarms andreminders—a challenging task for this at-risk population.

Accordingly, there exists a need for a device that provides an effectivesolution for both patients and health care providers regarding thepatient's adherence or compliance with complicated medication regimens.In particular, there exists a need for an automated medication adherencesystem to help organize the dispensing of many different sizes andshapes of pills and capable of managing a schedule of different pills tobe taken at different scheduled times. Such a system should enhance theinteraction between the patient and health care provider by allowing thehealth care provider to be alerted when the patient is not taking themedication according to the medication schedule.

SUMMARY

To minimize the limitations in the cited references, and to minimizeother limitations that will become apparent upon reading andunderstanding the present specification, the present specificationdiscloses a new and improved automated medication adherence system.

One embodiment may be an automated medication adherence system,comprising a housing and an electronic interface. The electronicinterface may use such data to automatically program the control logicfor operating the electromechanical operation of the adherence systemand the medication dispensing and scheduling functions using informationfrom pharmacy prescription records, pharmaceutical databases and medicalprofessionals. The electronic interface acquires data to schedule, alertand record therapies for pill and non-pill medications. The housing maycomprise a medication dispensing and lock-out module. The housing may beconfigured to contain a plurality of reservoirs wherein the plurality ofreservoirs may be configured for receiving, storing, and dispensing oneor more medications. The housing may comprise an access cover configuredto have closed and opened position. The plurality of reservoirs may beaccessible when the access cover is in the opened position. The accesscover may comprise a pill loading assembly wherein the pill loadingassembly may be configured to allow one or more medications to be loadedinto at least one of the plurality of reservoirs. The electronicinterface may comprise a computing component and multiple displaycomponents. The electronic interface may be on an exterior portion ofthe housing. The electronic interface may be programmable, such that theelectronic interface accepts data relating to one or more medicationsfrom pharmacies, medical professionals, database companies and otherauthorized users. Each of the plurality of reservoirs may be configuredto receive, store and dispense a homogenous type of medication from theone or more medications. Each of the plurality of reservoirs maycomprise one or more sensors and two successive stages, a first stageand a second stage. The one or more medications may be moved from thefirst stage to the second stage and then from the second stage to thepill delivery and lock-out module. The one or more medications may be aplurality of pills. The one or more sensors may be configured todetermine when a single pill of the plurality of pills passes througheach of the two successive stages and may control pill ejection fromstage 1 or 2, as appropriate. The automated medication adherence systemmay further comprise a rotating carrier configured to engage with theplurality of reservoirs, such that the plurality of reservoirs may beconfigured to rotate within the housing. The electronic interface mayrotate the plurality of reservoirs in response to the data relating tothe one or more medications. The data relating to the one or moremedications may be selected from the group of data gathered or createdthrough manipulation of data from prescription records, pharmaceuticaldatabases and proprietary data bases consisting of information such as:a pill identity; a user identity; a dosage schedule; medication format(pill or non-pill; such as inhalers, solutions, creams, etc.), pillimages, pharmaceutical indications for use, instructions (directions)for use, physical and chemical description of the medications, refills,side effect information and other information customarily used to manageand administer medications. The two successive stages may be configuredto be stacked, such that the first stage may be substantially above thesecond stage. Each of the two successive stages may comprise an opening,such that there are two openings, a first opening and a second opening.The first opening and the second opening may be selectively openable andclosable in response to the electronic interface. Each of the twosuccessive stages may receive and dispense the one or more medicationsthrough the two openings. Each of the plurality of reservoirs maycomprise a central agitation stalk, an outer wall; an inner wall;optionally one or more actuators and sensors. The central agitationstalk may be configured to be substantially contained within the innerwall, and the inner wall may be configured to be substantially containedwithin the outer wall. The central agitation stalk may be configured tobe rotatable within the inner wall. The central agitation stalk maycomprise a fin portion, a wave surface, and a ribbed cone surface. Thefin portion may comprise a plurality of fins that may be configured toprevent the one or more medications from clumping together. The wavesurface may be a base of the first stage; and the ribbed cone surfacemay be a base of the second stage. The ribbed cone may have ribs,undercuts, channels or any type of texture or geometry suitably totransport the pills to the stage 2 opening. A combination of wavesurface and the ribbed cone can be used at both stage 1 and stage 2. Theone or more actuators may be configured to rotate and agitate thecentral agitation stalk and at least one of the inner wall and the outerwall. The outer wall may comprise one or more outer wall portholes andone or more chutes. The inner wall may comprise one or more inner wallportholes. At least one of the one or more actuators may be configuredto rotate at least one of the inner wall and the outer wall, such thatthe inner wall and they outer wall may be rotated with respect to eachother. When the inner wall and the outer wall are rotated with respectto each other, the one or more outer wall portholes and the one or moreinner wall portholes may align to form the two openings that best matchthe solid geometry of the pill in that reservoir. The computingcomponent may comprise one or more logic algorithms. The one or moresensors, the one or more actuators, and the one or more logic algorithmsmay be configured to control the inner wall, the outer wall, and thecentral agitation stalk to ensure that the one or more medications maybe transferred, one pill at a time, from the first stage to the secondstage. The one or more sensors, the one or more actuators, and the oneor more logic algorithms may be configured to control the inner wall,the outer wall, and the central agitation stalk to ensure that the oneor more medications may be transferred, one pill at a time, from thesecond stage to the pill delivery and lock-out module. The electronicinterface may alert a user when the one or more medications aredispensed, such that a dispensed medication may be created. Theelectronic interface may also alert a user when the one or more non-pillmedications are required. The electronic interface may alert the user,one or more authorized individuals, and/or one or more health careproviders when a user has not removed the dispensed medication from thepill delivery and lock-out module in accordance with the data relatingto the one or more medications. The pill delivery and lock-out modulemay comprise three functions created by the translation of a pilltransporter. The pill transporter may create a holding tray, adispensing tray and a lock-out tray depending on the position of thepill transporter. If the pill transporter is in the neutral position,below the reservoir, it holds the pill or plurality of pills dispensedcreating a holding tray. The transporter moves forward to create andform a pill dispensing tray that opens toward the user when the user isready to take the pills. If the pills are not removed by the patientafter a predetermined or calculated amount of time, or erroneouslydispensed, the pill transporter may move in reverse to transfer thepills to a lock-out tray.

Another embodiment of the automated medication adherence system maycomprise: a housing; an electronic interface; and a rotating carrier.The housing may comprise a pill loading assembly and a pill delivery andlock-out module. The housing may be configured to contain a plurality ofreservoirs. The plurality of reservoirs may be configured for receiving,storing, and dispensing one or more medications. The rotating carriermay be configured to engage with the plurality of reservoirs, such thatthe plurality of reservoirs may be configured to rotate within thehousing. The housing may comprise an access cover configured to have aclosed and an opened position typically used for set-up and maintenance.The housing may comprise a reservoir loading door configured to have aclosed and an opened position to be accessed by the end user. Theplurality of reservoirs may be accessible when the access cover or thereservoir loading door are in the opened position. The reservoir loadingdoor may comprise a reservoir loading assembly configured to allow theplurality of reservoirs to be loaded. The electronic interface maycomprise a computing component and one or more display components. Theuser interface portion of the electronic interface may be on an exteriorportion of the housing. The electronic interface may be manuallyprogrammed by the user or automatically by accepting data relating tothe one or more medications, prescriptions, and prescription processes(e.g. refills, medication changes). The data relating to the one or moremedications may be selected from the group of data from pharmacyprescription records, providers prescription records, pharmaceuticaldatabases or proprietary databases consisting of: a pill identity; auser identity; a dosage schedule; medication format (pill or non-pill;such as inhalers, solutions, creams, etc.), pharmaceutical indicationsfor use, instructions (directions) for use, physical and chemicaldescription of the medications, pill images, instruction for use,refills, side effect information and other information customarily useto manage and administer medications. The electronic interface mayrotate the plurality of reservoirs in response to the data relating tothe one or more medications. Pills may be loaded through the pillloading assembly. Each of the plurality of reservoirs may be configuredto receive, store and dispense a homogenous type of the medication. Eachof the plurality of reservoirs may comprise one or more sensors and twosuccessive stages, a first stage and a second stage. The medication maybe moved from the first stage to the second stage and then from thesecond stage to the pill delivery and lock-out module. The twosuccessive stages may be configured to be stacked, such that the firststage may be substantially above the second stage. Each of the twosuccessive stages may comprise an opening, such that there may be twoopenings, a first opening and a second opening. The first opening andthe second opening may be selectively openable and closable in responseto the electronic interface. Each of the two successive stages mayreceive and dispense the medication through the two openings. Themedication may be a plurality of pills. The one or more sensors may beconfigured to determine when a single pill of the plurality of pillspasses through each of the two openings and triggers the immediateclosing of the opening. Each of the plurality of reservoirs may comprisea central agitation stalk, an outer wall, an inner wall, and one or moreactuators. The central agitation stalk may be configured to besubstantially contained within the inner wall, and wherein the innerwall may be configured to be substantially contained within the outerwall. The central agitation stalk may be configured to be rotatablewithin the inner wall. The central agitation stalk may comprise a finportion, a wave surface, and a ribbed cone surface. The fin portion maycomprise a plurality of fins that may be configured to prevent themedication from clumping together. The wave surface may be a base of thefirst stage. The ribbed cone surface may be a base of the second stage.The central agitation stalk may be configured to engage with at leastone of the one or more actuators in order to be rotated. The centralagitation stalk may comprise a plurality of gear teeth, which may beconfigured to be engaged with at least one of the one or more actuators.The one or more actuators may be configured to rotate the centralagitation stalk and at least one of the inner wall and the outer wall.The one or more actuators may be configured to rotate or agitate thecentral agitation stalk and at least one of the inner wall and the outerwall. The outer wall may comprise one or more outer wall portholes andone or more chutes. The inner wall may comprise one or more inner wallportholes. At least one of the one or more actuators may be configuredto rotate at least one of the inner wall and the outer wall, such thatthe inner wall and the outer wall may be rotated with respect to eachother. When the inner wall and the outer wall are rotated with respectto each other, the one or more outer wall portholes and the one or moreinner wall portholes may align to form the two openings. The computingcomponent may comprise one or more logic algorithms. The one or moresensors, the one or more actuators, and the one or more logic algorithmsmay be configured to control the inner wall, the outer wall, and thecentral agitation stalk to ensure that the medication may betransferred, one pill at a time, from the first stage to the secondstage. The one or more sensors, the one or more actuators, and the oneor more logic algorithms may be configured to control the inner wall,the outer wall, and the central agitation stalk to ensure that themedication may be transferred, one pill at a time, from the second stageto the pill delivery and lock-out module. The one or more logicalgorithms may be configured to schedule and control the dispensing ofmedication according to the corresponding prescription or plurality ofprescriptions and instructions for use.

Another embodiment of the medication reservoir for an automatedmedication adherence system may comprise two successive stages, a firststage and a second stage. The reservoir may be configured for receiving,storing, and dispensing a plurality of pills. Dispensing of theplurality of pills by the reservoir may be controlled by an electronicinterface. The plurality of pills may be moved from the first stage tothe second stage one pill at a time. The plurality of pills may be movedfrom the second stage to a pill delivery and lock-out module one pill ata time. Each of the two successive stages may comprise an opening, suchthat there may be two openings, a first opening and a second opening.The medication reservoir may further comprise one or more sensorswherein the one or more sensors may be configured to determine when asingle pill of the plurality of pills passes through each of the twoopenings. The first and second openings may be selectively openable andclosable in response to the electronic interface. The two successivestages may be configured to be stacked, such that the first stage may besubstantially above the second stage. The reservoir may further comprisea central agitation stalk, an outer wall, an inner wall, and one or moreactuators. The central agitation stalk may be configured to besubstantially contained within the inner wall, and the inner wall may beconfigured to be substantially contained within the outer wall. Thecentral agitation stalk may be configured to be rotatable within theinner wall. The central agitation stalk may comprise a fin portion, awave surface, and a ribbed cone surface. The fin portion may comprise aplurality of fins that may be configured to prevent the one or moremedications from clumping together. The wave surface may be a base ofthe first stage and the ribbed cone surface may be a base of the secondstage. The one or more actuators may be configured to rotate and agitatethe central agitation stalk and at least one of the inner wall and theouter wall. The outer wall may comprise one or more outer wall portholesand one or more chutes. The inner wall may comprise one or more innerwall portholes. At least one of the one or more actuators may beconfigured to rotate at least one of the inner wall and the outer wall,such that the inner wall and the outer wall may be rotated with respectto each other. The inner wall and the outer wall may be rotated withrespect to each other, the one or more outer wall portholes and the oneor more inner wall portholes may align to form the two openings. Theelectronic interface may comprise one or more logic algorithms. The oneor more sensors, the one or more actuators, and the one or more logicalgorithms may be configured to control the inner wall, the outer wall,and the central agitation stalk to ensure that the one or moremedications may be transferred, one pill at a time, from the first stageto the second stage. The one or more sensors, the one or more actuators,and the one or more logic algorithms may be configured to control theinner wall, the outer wall, and the central agitation stalk to ensurethat the one or more medications may be transferred, one pill at a time,from the second stage to the pill delivery and lock-out module.

It is an object to provide an automated medication adherence system toschedule medication dosage, medication replenishment, medicationstoppage, and treatment changeovers with minimal user intervention.

It is an object to provide an automated medication adherence system withthe ability to dispense a prescribed medication with an accuracy of upto 1:100,000.

It is an object to provide an automated medication adherence system tosafely manage frequent changes in medication treatment and manydifferent sizes of pills.

It is an object to provide an automated medication adherence system toprovide error-free medication loading by a patient with potentialphysical and cognitive limitations.

It is an object to provide an automated medication adherence system withmechanical pill handling that does not affect the integrity of themedication.

It is an object to provide an automated medication adherence systemcapable of acquiring and communicating prescription instructions.

It is an object to provide ease of use by enabling a system that uses asingle type of reservoir that can be programmed to handle pills of allsizes, solid geometries and construction methods. The reservoir can beused at any position within the rotating carrier.

It is an object to provide and record “pro re nata” (on demand or asneeded) medication events to patients, if required.

It is an objective to provide maximum patient safety avoidingover-dosage or wrong dosage or wrong medication).

It is an object to overcome the limitations of the prior art.

Other features and advantages will become apparent to those skilled inthe art from the following detailed description and its accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings show illustrative embodiments, but do not depict allembodiments. Other embodiments may be used in addition to or instead ofthe illustrative embodiments. Details that may be apparent orunnecessary may be omitted for the purpose of saving space or for moreeffective illustrations. Some embodiments may be practiced withadditional components or steps and/or without some or all components orsteps provided in the illustrations. When different drawings contain thesame numeral, that numeral refers to the same or similar components orsteps.

FIG. 1 is an illustration of a perspective view of one embodiment of theautomated medication adherence system.

FIG. 2 is an illustration of a perspective view of one embodiment of acentral agitation stalk.

FIG. 3 is an illustration of a cross-section view of one embodiment of areservoir that is contained within the automated medication adherencesystem.

FIG. 4 is an illustration of a perspective view of one embodiment of areservoir that is contained within the automated medication adherencesystem.

FIG. 5 is an illustration of an exploded view of one embodiment of areservoir that is contained within the automated medication adherencesystem.

FIG. 6 is an illustration of a cross-section view of one embodiment ofthe interior of the automated medication adherence system and shows thesensors and actuators.

FIG. 7 is an illustration of a close-up view of one embodiment of thesecond stage of a reservoir that is contained within the automatedmedication adherence system.

FIG. 8 is an illustration of a close-up view of one embodiment of areservoir that is contained within the automated medication adherencesystem with continuously variable openings to best match the solidgeometry of the pill loaded into a specific reservoir.

FIG. 9A is an illustration of a close-up view of one embodiment of thepill delivery and lock-out module in its neutral position that iscontained within the automated medication adherence system.

FIG. 9B is an illustration of a close-up view of one embodiment of thepill delivery and lock-out module in its forward position that iscontained within the automated medication adherence system.

FIG. 9C is an illustration of one embodiment of the pill delivery andlock-out module in its reverse (lock-out tray) position that iscontained within the automated medication adherence system.

FIG. 10 is an illustration of one embodiment of the reservoir covermechanism that opens and closes a reservoir fill opening that iscontained within the automated medication adherence system.

FIG. 11 is an illustration of one embodiment of the reservoir loadingdoor and the pill loading assembly that are contained within theautomated medication adherence system.

FIG. 12 is a flow block diagram of one embodiment of the method ofmedication moving through the first stage of the automated medicationadherence system.

FIG. 13 is a flow block diagram of one embodiment of the method ofmedication moving through Stage 2 of the automated medication adherencesystem.

FIG. 14 is a flow block diagram of one embodiment of the method oftaking medication on an as-needed or away from home basis.

FIG. 15 is a flow block diagram of one embodiment of the method ofprogramming the reservoirs and dispense logic using one or morealgorithms using the computing component.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

In the following detailed description of various embodiments, numerousspecific details are set forth in order to provide a thoroughunderstanding of various aspects of the embodiments. However, theembodiments may be practiced without some or all of these specificdetails. In other instances, well-known procedures and/or componentshave not been described in detail so as not to unnecessarily obscureaspects of the embodiments.

While some embodiments are disclosed here, other embodiments will becomeobvious to those skilled in the art as a result of the followingdetailed description. These embodiments are capable of modifications ofvarious obvious aspects, all without departing from the spirit and scopeof protection. The Figures, and their detailed descriptions, are to beregarded as illustrative in nature and not restrictive. Also, thereference or non-reference to a particular embodiment shall not beinterpreted to limit the scope of protection.

In the following description, certain terminology is used to describecertain features of one or more embodiments. For purposes of thespecification, unless otherwise specified, the term “substantially”refers to the complete or nearly complete extent or degree of an action,characteristic, property, state, structure, item, or result. Forexample, in one embodiment, an object that is “substantially” locatedwithin a housing would mean that the object is either completely withina housing or nearly completely within a housing. The exact allowabledegree of deviation from absolute completeness may in some cases dependon the specific context. However, generally speaking, the nearness ofcompletion will be so as to have the same overall result as if absoluteand total completion were obtained. The use of “substantially” is alsoequally applicable when used in a negative connotation to refer to thecomplete or near complete lack of an action, characteristic, property,state, structure, item, or result.

As used herein, the terms “approximately” and “about” generally refer toa deviance of within 5% of the indicated number or range of numbers. Inone embodiment, the term “approximately” and “about”, may refer to adeviance of between 1-10% from the indicated number or range of numbers.

FIG. 1 is an illustration of a perspective view of one embodiment of theautomated medication adherence system. As shown in FIG. 1, oneembodiment of the automated medication adherence system 100 maycomprise: a housing 101, a bar code reader 105, electronic interfaces110, 111 a plurality of reservoirs 115, one or more sensors (shown inFIG. 6), and at least one pill delivery and lock-out module 106. Thehousing 101 may be any suitable shape and size for containing one ormore reservoirs 115. For example, the housing 101 may be cubed shaped,as shown in FIG. 1. The housing 101 may define an exterior and aninterior of the automated medication adherence system 100. The exteriormay comprise a bottom surface that is capable of supporting theautomated medication adherence system 100 on a flat surface, such as adesk or countertop. The exterior may comprise a top access cover 120,hereinafter referred to as an access cover, and a reservoir loading door121 (shown in FIG. 11). The access cover 120 may be movable to an openposition for manually placing reservoirs 115 into the interior orremoving the reservoirs 115 or to maintain the system. The access cover120 may preferably be movable to a closed and lockable position forpreventing manual access to the reservoirs 115. Preferably, thereservoir loading door 121 may be used to load or remove reservoirs 115by the end user. The lockable reservoir loading door 121 may be movableto an open position for manually placing or removing reservoirs 115 intothe interior or removing the reservoirs 115 one at a time. Theft ofprescription medicines by relatives of the prescription holder may be aproblem solved by locking the access cover 120 and reservoir loadingdoor 121. When the access cover 120 is in a closed lockable position, apill loading assembly 125 located on at least one portion of the accesscover 120 may provide access between the exterior of the housing 101 andthe interior of the housing 101 in order to load medication into thereservoirs 115. Typically, gravity may be used to assist in loadingmedication through the pill loading assembly 125 into the reservoirs115. The interior of the housing 101 may form an interior space that issufficiently large to completely enclose the structural components ofthe automated medication adherence system 100. There may preferably betwelve reservoirs 115, which may preferably house at least sixty (60) ofthe largest prescribed pills each. A movable carrier, hereinafterreferred to as a rotating carrier, may hold the reservoirs 115 inposition wherein the electronic interfaces 110, 111 may actuate a motorto rotate the rotating carrier in order to align a pre-determinedreservoir 115 with the pill loading assembly 125 of the access cover120, such that medication may travel through the pill loading assembly125 and into the correct, known, and identified reservoir 115. Therotating carrier may then rotate again to allow a user to loadadditional medications into different reservoirs 115. Each reservoir 115may preferably house a homogenous type of medication, but this singletype of medication may be one of many different sizes or shapes. Thereservoirs 115 may comprise a medication preservation system to avoidcross-contamination, such as ultraviolet light protection, dust,excessive humidity, lids, and/or removable films. Additionally, in orderto prevent contamination, a new reservoir 115 may be used each and everytime a new medication is loaded and the medication may not contact orreuse any conduit except the pill loading assembly 125 of the accesscover 120 and the pill delivery and lock-out module 106.

The reservoirs 115 are preferably configured to isolate a dosage of themedication contained in the specific reservoir 115 and thenautomatically deliver the dosage to the pill delivery and lock-outmodule 106. The dosage may be one pill or more than one pill, dependingon the prescription. The system may repeat the dispensing process ifmultiple pills of the same type are simultaneously required. Preferablythe rotating carrier rotates, such that the appropriate reservoir 115 isnext to the pill delivery and lock-out module 106. The reservoir 115 maythen deliver the dosage to the pill delivery and lock-out module 106.The rotating carrier may then rotate again, such that the next reservoir115 may deliver a dosage of a different pill type. Once all of thedosages for that dosage time period have been delivered, the user maythen take the dosage from the pill delivery and lock-out module 106.Under certain circumstances, it may be recommendable to deliver one pilltype at a time, instead of all pills scheduled at the same time. Thesystem algorithms may be capable to handle these instructions for use.

The housing 101 of the automated medication adherence system 100 mayhave a pill delivery and lock-out module 106, which may be a drawer,door, swing door, chute, and/or tray. The pill delivery and lock-outmodule 106 may be open or may be a locked portion, which is onlyunlocked for the specific user at a specific time. Once the entiredosage is in the pill delivery and lock-out module 106, the automatedmedication adherence system 100 may preferably notify the user toretrieve the dosage. This notification may be an audible alert, visualalert, vibration, and/or a wireless electronic communication to anelectronic device used by the user. The pill delivery and lock-outmodule 106 may have one or more sensors that determine the status of thedosages within the pill delivery and lock-out module 106. The pilldelivery and lock-out module 106 opens to deliver medications to user.

The pill delivery and lock-out module 106 may comprise a lock-out traythat opens in the event that a dosage is not removed from the dispensingtray configuration of the pill delivery and lock-out module 106 by theuser. In this manner, the next dosage does not get mixed up with themissed dosage, avoiding an overdose. The system may record allmedication events and a high frequency of pills transferred to thelock-out module may constitute a pattern of non-adherence. Preferably,if medication non-adherence becomes an issue, a notification may be sentto the user, pharmacy, care giver and/or a health care provider. In thismanner, non-adherence can be dealt with appropriately.

Although a rotating carrier is shown as the mechanism that moves thereservoirs 115 within housing 101, the motion of the reservoirs 115 maybe accomplished by other devices, including actuators, pulleys, slides,and the like.

A bar code reader 105 may be positioned on the exterior of the housing101, or at another appropriate location, to read the medicationprescription record number and other bar-coded information needed forautomatic programming and ease of use by a user of the automatedmedication adherence system 100. For example, the bar code reader 105may enable the recognition of data relating to the medication, includinga pill identity, pill type, pill size, pill shape, a user identity, adosage schedule, dosage information, and potential side effects that maybe used to automatically program the automated medication adherencesystem. Therefore, the automated medication adherence system 100 doesnot require any programming by a user. Prior to loading medication intoa reservoir 115, the bar code reader 105 may allow the user to send thedata relating to the medication to the electronic interface 110 forprogramming each of the reservoirs 115 with the specific informationrequired to accurately dispense the medication to be loaded.

Likewise, the electronic interfaces 110, 111 may be positioned on theexterior of the housing 101, or at another appropriate location, forease of use by a user of the automated medication adherence system 100.FIG. 1 shows that the electronic interfaces may be a permanent fixtureand/or a removable hand held computing device. The electronic interfaces110,111 may be used for accomplishing various interface and notificationfunctions. For example, the electronic interface 110,111 may also bemanually programmed with data relating to the medication, including apill identity, pill type, pill size, pill shape, pill images, scheduletime, daily frequency, a user identity, a dosage schedule, dosageinformation, not to exceed amounts, instructions for use and potentialside effects. The electronic interfaces 110,111 may enable programmingof each of the reservoirs 115 with the specific information about themedication to be held in the respective reservoir 115. The electronicinterface may facilitate the openings, agitation, and rotationalparameters of each reservoir 115 to match the geometry, size andconstruction of each pill type so each reservoir 115 may be capable ofaccurately dispensing any pill type. The electronic interfaces 110, 111may comprise a computing component and a display/interactive component.The computing component may control the one or more reservoirs 115, suchthat the precise dosage of medication is delivered from the reservoirs115 to the pill delivery and lock-out module 106 each and every time onthe dosage schedule. The display/interactive components may preferablybe a touch screen so the patient can acknowledge and authorize certainsteps, initiate certain actions, and provide a high level ofinteractivity and operability.

FIG. 2 is an illustration of a perspective view of one embodiment of acentral agitation stalk for the reservoirs. FIG. 2 shows that eachreservoir within the automated medication adherence system may comprisea central agitation stalk 200. The central agitation stalk 200 maygenerally provide rotation and agitation within the reservoir, such thateach reservoir may receive, store, and dispense pills, tablets, andcapsules of various sizes and geometries accurately and precisely. Thecentral agitation stalk 200 may comprise fin portion 205, a wave surface210, a ribbed cone surface 215, and gear teeth 220. When a user loadsmedication into a reservoir, the fin portion 205 may prevent themedication from inadvertently clumping together. The medication maygenerally fall onto the wave surface 210 and be stored until theelectronic interface causes the reservoir to dispense the medication. Ata desired and/or scheduled time period, a drive mechanism engages withgear teeth 220 and causes the central agitation stalk 200 to rotate inorder to move the medication on the wave surface 210. This rotationalmovement may be combined with an agitation movement in order to move—onepill at a time—the medication from the first stage (wave surface 210) tothe lower or second stage (ribbed cone surface 215). The medication mayreside on the ribbed cone surface 215 until it is ready to be dispensed,one pill at a time, into a pill delivery and lock-out module. The finportion 205, wave surface 210, and ribbed cone surface 215 may berotated and/or agitated simultaneously, or separately, such that onlyone or two rotate, while the others remain still.

FIG. 3 is an illustration of a cross-section view of one embodiment of areservoir that is contained within the automated medication adherencesystem. FIG. 3 shows that each reservoir 115 within the automatedmedication adherence system may comprise a generally cylindricaltwo-stage device for storing and dispensing medication. The cylindricalreservoir 115 may comprise a stalk housing 299, also referred to as areservoir housing, and a central agitation stalk 200. As shown in FIG.3, the stalk housing 299 may comprise a funnel shaped hopper 301 and twooverlapping walls, outer 300 and inner wall 510. The central agitationstalk 200, inner wall 510, and outer wall 300 may delineate theboundaries of the first stage 305 and the second stage 310. The firststage 305 may comprise a receptacle for storing medication, and thentransfer the medication, in a controlled manner, to the second stage310. Once the reservoir 115 to be loaded with medication is aligned withthe pill loading assembly in the access cover, a user may loadmedication via the top of the reservoir 115 into the first stage 305 ofthe reservoir 115. FIG. 3 shows that the hopper 301 may be wide andfunnel shaped in order to allow loading of the medication through theaccess cover without spilling any pills or medication and to maximizestorage capacity. The medication may fall past the fin portion 205 andthe central agitation stalk 200 may rotate in order for the medicationto settle onto the wave surface 210. The first stage 305 may alsocomprise a first opening 315 around the periphery such that themedication may exit the first stage 305 and enter the second stage 310.Sensors, rotational and agitation actuators, and logic algorithms mayensure that only a specified number of pills, usually one or two pills,are transferred—one pill at a time—from the first stage 305 to thesecond stage 310. The second stage 310 may comprise a second opening 316for allowing the medication to be dispensed, one pill at a time, to thepill delivery and lock-out module. The first and second openings 315,316 may be created when openings in the inner and outer walls 510, 300overlap through rotational motion to create an opening that best matchesthe pill geometry. Proprietary algorithms may use information from thepharmacy prescription records and pharmaceutical and/or proprietarydatabases to calculate the reservoir 115 openings 315, 316 and certainagitation and rotation parameters required to dispense the pills withhigh degree of accuracy. FIG. 3 also shows that the openings 315, 316may comprise or be connected to chutes 405 and 410. As the medicationpill passes through openings 315 or 316, the chutes 405, 410 may directit to travel along a predetermined path.

In other embodiments, the stalk 200 housing may be of a unitary design,wherein rotational, actuation, and agitation are used to move themedication from the first stage 305 to the second stage 310 and from thesecond stage 310 to the pill delivery and lock-out module.

FIG. 4 is an illustration of a perspective view of one embodiment of areservoir that is contained within the automated medication adherencesystem. FIG. 4 shows that each reservoir 115 within the automatedmedication adherence system may comprise a hopper 301 and a generallycylindrical outer wall 300. The hopper 301 may comprise or be connectedto a top portion 400 of the reservoir 115. The top portion 400 may becovered by a rotating reservoir cover assembly 1105 that simultaneouslyopens and closes all reservoirs 115, allowing access from the pillloading assembly to the reservoir 115 when the rotating reservoir coverassembly 401 is open and preventing contamination and allowingtransportation when the rotating reservoir cover assembly 1105 isclosed. Additionally, the outer wall 300 may comprise or otherwise beconnected to one or more chutes 405, 410. The first stage 305 of thereservoir 115 may comprise a first chute 405 to help guide medicationtraveling from the first stage 305 to the second stage 310. The firstchute 405 may be an extension of the first opening 315. Likewise, thesecond stage 310 of the reservoir 115 may comprise a second chute 410 tohelp guide medication being dispensed into a pill delivery and lock-outmodule. The second chute 410 may be an extension of the second opening316.

FIG. 4 also shows show the inner wall 510 may be comprised of gear teeth511 and how the inner wall 510 may be substantially contained within theouter wall 300, such that the inner wall 510 may be turned, via gearteeth 511, within the outer wall 300. As shown, the gear teeth 511 maybe preferably accessible through the outer wall 300. FIG. 4 also showshow the gear teeth 220 may be accessible through the outer wall 300.

FIG. 4 also shows how the hopper 301 may be designed to contain and befilled with medication, which may be prevented from clumping by therotation of the fin portion 205.

FIG. 5 is an illustration of an exploded view of one embodiment of areservoir that is contained within the automated medication adherencesystem. FIG. 5 shows that each reservoir 115 within the automatedmedication adherence system may comprise a multi-component receptacle.FIG. 5 shows that the reservoir 115 may comprise a central agitationstalk 200, walls 300, 510, and one or more retaining rings 505. Thecentral agitation stalk 200 may generally provide a rotational andagitation motion such that each reservoir 115 may receive, store, anddispense medication in an extremely precise and accurate manner. Theouter wall 300 and the inner wall 510 may rotate relative to each other,which in turn, may create different sizes of openings around theperiphery such that medication may pass between from the first stage tothe second stage or be dispensed into the pill delivery and lock-outmodule. The retaining rings 505 may provide support to the top andbottom portions of the outer wall 300 and assist the outer wall incontaining inner wall 510. The rings 505 may also hold the stalkvertically in place within the inner wall 510, as shown in FIG. 6.

FIG. 6 is an illustration of a cross-section view of one embodiment ofthe interior of the automated medication adherence system. FIG. 6 showsthat the automated medication adherence system may comprise one or moresensors 605, 610 and one or more actuators 601, 602. The sensor 605 maybe configured to sense when a single pill, or a specific dosage of pillsmoves from the first stage 305 to the second stage 310. The sensor 605may be an optical sensor, preferably a camera sensor, but other types ofsensors may be used. The sensor 605 may preferably be positioned tomonitor movement and ejection of a pill through the first opening 315.The sensor 610 may be configured to sense when a single pill, or aspecific dosage of pills moves from the second stage 310 to the pilldelivery and lock-out module. The sensor 610 may be an optical sensor,preferably a camera sensor, but other types of sensors may be used. Thesensor 610 may preferably be positioned to monitor movement and ejectionof a pill through the second opening 316.

The sensors 605, 610 are preferably connected to the computing componentof electronic interface, such that the automated medication adherencesystem can detect when a pill has transferred to the second stage 310 orto the pill delivery and lock-out module.

FIG. 6 also shows how the actuators 601 and 602 interconnect with theinner wall 510 and the central agitation stalk 200, respectively,through the gear teeth 511 and 220, respectively. The actuators 601, 602are controlled by the computing component of the electronic interface,such that the automated medication adherence system may accurately andprecisely dispense medication of almost any size or shape. The actuator601, as shown, may cause the inner wall 510 to rotate, such that thefirst and/or second opening 316 may be created and/or closed as neededto move the medication and control the ejection through the automatedmedication adherence system. The outer wall 300 and the inner wall 510each may have openings that, when aligned by the rotation of the innerwall 510, create openings 316. The actuator 601 may also provideagitation, which may de-clump the medication, in the event that a sensor605, 610 detects such clumping, and/or that may cause the medication toeject through the openings 315, 316 in a controlled manner.

The actuator 601, as shown, may cause the wave surface 210 to rotate,such that the medication resting on the wave surface 210 is brought tothe first opening. Though agitation and rotation of actuators 601 and/or602, the pill on the wave surface 210 may be caused to go through thefirst opening and down to the second stage 310, ideally one pill at atime. The sensor 605 may then inform the computing component that asingle pill has successfully been moved and the actuator 601 may thenclose the first opening by reversing (or continuing) the rotation of theinner wall 510. Similarly, the actuator 602, as shown, may cause theribbed cone surface 215 to rotate, such that the medication resting onthe ribbed cone surface 215 may be brought to the second opening 316.Though agitation and rotation of the actuators 602 and/or 601, only onepill on the ribbed cone surface 215 may be caused to go through thesecond opening 316 and out to the pill delivery and lock-out module. Thesensor 610 may then inform the computing component that the single pillhas successfully been moved and the actuator 602 may then close thesecond opening 316 by reversing (or continuing) the rotation of theinner wall 510. This process may be repeated until the correct dosagehas been delivered from to the pill delivery and lock-out module.

FIG. 7 is an illustration of a close-up view of one embodiment of thesecond stage of a reservoir that is contained within the automatedmedication adherence system. FIG. 7 shows that the second stage 310 of areservoir 115 may house medication on the ribbed cone surface 215 of thecentral agitation stalk 200 prior to dispensing the medication into thepill delivery and lock-out module. Preferably, the amount of medicationon the ribbed cone surface 215 is only a small number of pills, and maybe a single dosage of the medication to be delivered to the pilldelivery and lock-out module. The actuator may align the outer wall 300and the inner wall of the reservoir 115 such that the opening 316 (shownin FIG. 8) is not yet formed. Thus, the medication in the second stage310 cannot yet exit. The ribbed cone surface 215 may be agitated by theactuator at specific amplitudes and frequencies in order to facilitatethe separation of the medication on the ribbed cone surface 215, inorder to line up one pill behind the other so that the medication can betransferred, one pill at a time, to the pill delivery and lock-outmodule. The actuator may continue (or reverse) the rotation of theribbed cone surface 215 until each pill conforms to its exit position,preferably lengthwise. Additionally, using pre-programmed medicationdata and algorithms, the rotation and agitation parameters may adjustthe opening 316 to best match the dimensions of the pill.

FIG. 8 is an illustration of a close-up view of one embodiment of areservoir that is contained within the automated medication adherencesystem with continuously variable openings to best match the solidgeometry of the pill loaded into a specific reservoir. FIG. 8 shows thatthe second stage 310 of a reservoir 115 may house medication on theribbed cone surface 215 of the central agitation stalk 200 prior todispensing the medication into a pill delivery and lock-out module. Theouter wall 300 and the inner wall 510 of the reservoir 115 may bealigned such that the second opening 316 around the periphery is formedand accessible for medication dispensing at a desired period of time.When the medication reaches the second opening 316 around the periphery,the medication, through gravity, may pass through the second opening316. Agitation may be provided by the central agitation stalk 200 inorder to assist the medication in passing through the second opening316. Algorithms for agitation and rotation parameters may bepre-programmed into the electronic interface and may include specificamplitudes and frequencies in order to facilitate the travel of themedication through the automated medication adherence system. Theautomated medication adherence system may accommodate medicationgenerally ranging from about 3 to about 28 millimeters, but thereservoir size, openings, and agitation and rotation parameters may bechanged to increase the range of pill sizes and solid geometries. Oncethe dosage of medication has been dispensed, the electronic interfacemay close the second opening 316 and provide an alert that themedication is available for consumption.

FIG. 9A is an illustration of a close-up view of one embodiment of thepill delivery and lock-out module in its neutral (holding pill deliveryand lock-out module) position that is contained within the automatedmedication adherence system. FIG. 9A shows that the reservoirs 115 arepreferably configured to isolate a dosage of medication contained in thespecific reservoir 115 and then deliver the dosage to the pill deliveryand lock-out module 106. The pill delivery and lock-out module 106 maycomprise a dispensing tray 1000, a transporter 1005, and a lock-outtray, which is created by the axial movement of the transporter 1005 inrelation to the other components described below. The pill delivery andlock-out module 106 may be substantially housed within the interior ofthe automated medication adherence system 100 when holding medication.Preferably, the rotating carrier 1010 rotates, such that the appropriatereservoir 115 may be next to the pill delivery and lock-out module 106.Then an actuator may cause the reservoir 115 to rotate, such that themedication resting on the ribbed cone surface may brought to the secondopening 316. Through agitation and rotation of the actuators, themedication on the ribbed cone surface may be caused to go through thesecond opening 316 and out to the pill delivery and lock-out module 106.The dosage of medication may be one or more pills. The dosage may comefrom one or more reservoirs 115. Once the entire dosage is within thedispensing tray 1000, the user may then be signaled to collect thedosage. A sensor 610 may inform the computing component that themedication has successfully been moved and the actuator may close thesecond opening 316 by rotation of the inner wall of the reservoir 115.This process may be repeated until the correct dosage of medication(s)has been delivered to the pill delivery and lock-out module 106. Thesensor 610 may preferably be positioned to monitor movement ofmedication through the second opening 316 to the pill delivery andlock-out module 106. The sensor 610 may take pictures and store dataconfirming that a dosage and/or total dosage of medication wasdispensed. When the prescribed dose of medication for that dosage timeperiod has been delivered to the pill delivery and lock-out module 106,the pill delivery and lock-out module 106 may move to the exterior ofthe automated medication adherence system 100 to a forward position so auser may then take the dosage of medication from the pill delivery andlock-out module 106. Additionally, notification may alert a user themedication is ready for consumption.

FIG. 9A also shows that if one or more pills were erroneously dispensed,the pill delivery and lock-out module 106 may remain in the neutralposition, below the reservoir 115, and hold the pills that weredispensed from the second opening 316. The transporter 1005 may alsomove in reverse to transfer any erroneously dispensed pills to alock-out tray 1015 (shown in FIG. 9C). Preferably, when the lock-outtray 1015 operates, a notification may be sent to the user, anyauthorized individual, and/or a health care provider. In this manner,missed or incorrect dosages may be dealt with appropriately.

FIG. 9B is an illustration of a close-up view of one embodiment of thepill delivery and lock-out module in a forward position. FIG. 9B showswhen one or more pills are dispensed from the second opening 316 of areservoir 115, the transporter 1005 may move forward to eject thedispensing tray 1000 into a forward position when the patient is readyto take the pills. If the pill delivery and lock-out module 106 is inthe forward position and the pills are not removed by the patient aftera period of time, the transporter 1005 may also move in reverse totransfer the pills to a lock-out tray 1015. A dosage of medication mayrest within the pill delivery and lock-out module 106 until themedication is ready to be collected by a user.

FIG. 9C is an illustration of one embodiment of the pill delivery andlock-out module in its reverse (lock-out tray) position that iscontained within the automated medication adherence system. FIG. 9Cshows that if a dosage of medication is not retrieved after apre-determined period of time or if the dosage of medication has beendispensed incorrectly, the transporter 1005 may move or slide backwardand guide the medication from the dispensing tray 1000 of the pilldelivery and lock-out module 106 to a lock-out tray 1015. Once themedication is stored in the lock-out tray 1015, a user adherence recordmay be updated and the transporter 1005 may move back into its neutralposition. In this manner, the next dosage may not get mixed up with theprevious dosage, avoiding an over dosage, and an incorrect dosage may beheld in the lock-out tray 1015. Preferably, when the lock-out tray 1015operates, a notification may be sent to the user, one or more authorizedindividuals, and/or one or more health care providers. In this manner,missed or incorrect dosages may be dealt with safely and appropriatelyand double or wrong dosage is prevented. FIG. 9C shows that actuator1020 may be used to slide the transporter 1005 back and forth todispense or retrieve an unused or incorrect dosage.

FIG. 10 is an illustration of one embodiment of the reservoir covermechanism that opens and closes a reservoir fill opening that iscontained within the automated medication adherence system. FIG. 10shows the automated medication adherence system 100 may comprise anaccess cover. The access cover may be movable to an open or closedposition. When the access cover is in a closed lockable position, a pillloading assembly located on at least one portion of the top access covermay provide access between the exterior of the housing and the interiorof the housing in order to load medication into the reservoirs 115. Arotating carrier 1010, may hold the reservoirs 115 in position whereinthe electronic interface may actuate a motor to rotate the rotatingcarrier 1010 in order to align a pre-determined reservoir 115 with thepill loading assembly of the access cover, such that medication maytravel through the pill loading assembly and into the correct, known,and identified reservoir 115. The rotating carrier 1010 may then rotateagain to allow a user to load additional medications into differentreservoirs 115. The interior of the housing may also comprise a rotarylid 1105. The rotary lid 1105 may be positioned above the reservoirs 115and may passively rotate in response to the clockwise or counterclockwise rotation of the rotating carrier 1010. The rotary lid 1105 mayprovide access to the interior of the reservoirs 115 when the openings1110 in the rotary lid 1105 align with the openings of the rotatingreservoir cover assembly 401. Likewise, the rotary lid 1105 may preventaccess to the interior of the reservoirs 115 when the openings 1110 inthe rotary lid 1105 do not align with the openings of the rotatingreservoir cover assembly 401. An additional fixed cover may be presentabove the rotary lid 1105.

FIG. 11 is an illustration of one embodiment of the automated medicationadherence system showing the reservoir loading door and the pill loadingassembly. FIG. 11 shows the reservoir loading door 121 may be used toload or remove reservoirs 115 by the end user. The reservoir loadingdoor 121 may be movable to an open position 1200 for manually placing orremoving reservoirs 115 into the interior of the automated medicationadherence system 100 or removing the reservoirs 115 one at a time.Preferably, the reservoir loading door 121 may slide individualreservoirs 115 in and/or out of the interior of the automated medicationadherence system 100. When the reservoir loading door 121 is not in use,the reservoir loading door 121 may fold up in a vertical direction andform part of the exterior of the housing 101.

FIG. 11 also shows when the access cover 120 is in a closed lockableposition, a pill loading assembly 125 located on at least one portion ofthe access cover 120 may provide access between the exterior of thehousing 101 and the interior of the housing 101 in order to loadmedication into the reservoirs 115. Typically, gravity may be used toassist in loading medication through the pill loading assembly 125 intothe reservoirs 115. The pill loading assembly 125 may also comprise apill wiper 1205, which may wipe medication into the reservoirs 115. Whenthe pill loading assembly 125 is not in use, the pill wiper 1205 mayremain in a closed position, preventing access to the pill loadingassembly 125.

FIG. 12 is a flow block diagram of one embodiment of the method ofmedication moving through the first stage of the automated medicationadherence system 1300. FIG. 12 shows that after a user loads medicationinto the automated medication adherence system, the medication mayremain in the first stage 1305 of the reservoir for storage until themedication is ready to be transferred to the second stage. The agitatormay agitate the reservoir using proprietary algorithms at set timeintervals in order to prevent the medication from sticking to oneanother 1310. Similarly, the reservoir may agitate using calculatedalgorithms to begin transporting the medication toward the opening inthe first stage using calculated rotation and counter rotationparameters. Preferably, the agitator may be optimized for a particularpill size and shape 1315.

Accordingly, the opening in the first stage may start opening based onthe medication's dimensions 1320. The opening may increase from aminimum clearance level 1325 until it has reached the maximum clearancelevel 1330. If the medication has not dispensed into the second stage,the agitator may counter rotate a number of full turns 1335. This mayhelp the pills realign on the surface and may clear pill jams within thefirst stage. The sensor may detect when a single pill has been dispensedand immediately close the opening in the first stage. The medicationshould now be in stage two 1345.

FIG. 13 is a flow block diagram of one embodiment of the method ofmedication moving through the second stage of the automated medicationadherence system 1400. FIG. 13 shows that after that the medication maytravel from the first stage to the second stage 1405. Once themedication is in the second stage, the agitator may rotate in order toline the medication up in single line along the surface of the secondstage, if more than one pill was transferred from the first stage to thesecond stage 1410. The opening of the second stage may open based on themedication's dimensions 1415 and the agitator may slowly begin to rotate1420 in order to help the medication dispense into the pill delivery andlock-out module. If the medication did not dispense, the agitator mayrotate for two full turns 1425 in order to dispense the medication. Asensor may detect when a single pill has been dispensed into the pilldelivery and lock-out module and the opening of the second stage mayclose and the agitator may stop rotating 1430. The pills may fall outvia gravity from the second stage opening as the pills are rotated pastthe second stage opening.

FIG. 14 is a flow block diagram of one embodiment of the method oftaking medication on an as-needed or away from home basis 1500. When auser engages with the automated medication adherence system, theautomated medication adherence system may inquire as to the user'sidentity and authentication 1505. Although the automated medicationadherence system does not require the user to do any programming, theuser may be required to input, scan, or otherwise upload informationrelating to the user, the medication, the prescribing entity, and/or theprescription. If a user would like the use the automated medicationadherence system for on demand medication 1510, the user may be directedto the Main Menu of the computing component 1515. Otherwise, the usermay select a medication event such as an as-needed basis or away fromhome basis 1520. If the user decides to take the medication on anas-needed basis, the user may be prompted to select a pill type 1525.The medication may then undergo a special dispensing routine 1545. Theautomated medication adherence system may then dispense the medicationand a user may remove the medication for consumption 1555. If the userhas exceeded the maximum number of on-demand medications allowed over apre-determined period of time, the system may not dispense anymoremedication and may alert the user and a medical professional of thiscondition. If the user decides to take the medication on an away fromhome basis, the user may have to decide whether they will be away fromhome for more than one day 1530. If the user may be away from home formore than one day, the user may enter the number of days they will beaway from home 1538. If the user will not be away from home for morethan one day, the user may specify when they will be away, for example,in the morning and/or the evening 1535. The automated medicationadherence system may then calculate the type and number of pillsrequired by the user 1540. The medication may then undergo a specialdispensing routine 1545. The automated medication adherence system maythen dispense the medication and a user may remove the medication forconsumption 1555.

FIG. 15 is a flow block diagram of one embodiment of the method ofprogramming the reservoirs and dispense logic using one or morealgorithms using the computing component 1600.

FIG. 15 shows the user information and data relating to the medicationmay be transmitted to and from an automated medication adherence system1610, by one or more health care providers 1615, and/or pharmacists 1620through an online connection, bar code scan, or direct upload. Forexample, the electronic interface 1625 may be manually programmed withdata relating to the medication, including a pill identity, pill type,pill size, pill shape, pill images, schedule time, daily frequency, auser identity, a dosage schedule, dosage information, not to exceedamounts, instructions for use and potential side effects. The electronicinterface 1625 may enable programming of each of the reservoirs with thespecific information about the medication to be held in the respectivereservoir. Additionally, the electronic interface may utilize a bar codereader, positioned on the exterior of the automated medication adherencesystem 1610, or at another appropriate location, to read the medicationprescription record number and other bar-coded information needed forautomatic programming and ease of use by a user 1605 of the automatedmedication adherence system 1610. For example, the bar code reader mayenable the recognition of data relating to the medication, including apill identity, pill type, pill size, pill shape, a user identity, adosage schedule, dosage information, and potential side effects.Therefore, the automated medication adherence system 1610 does notrequire any programming by a user 1605. Prior to loading medication intoa reservoir, the bar code reader may allow the user 1605 to send datarelating to the medication to the electronic interface 1625 forprogramming each of the reservoirs with specific information about themedication to be loaded.

The data relating to the medication may be stored in a cloud application1630. The cloud application 1630 may also receive data relating to themedication from a pharmacy software interface 1635. When a health careprovider 1615 writes a prescription for the user 1605, the prescriptionmay be stored in a health care provider software interface 1640 andtransmitted as an e-prescription 1645 to the pharmacy software interface1635. The pharmacy software interface 1635 may work in conjunction witha pharmacist 1620 to dispatch the appropriate medication for the user1605. Additionally, the pharmacy software interface 1635 may transmitthe e-prescription 1645 to the cloud application 1630 for programmingthe electronic interface 1625 of the automated medical adherence system1610. Data relating to the medication may also be stored in a medicationdatabase 1655.

FIG. 15 also shows that the automated medication adherence system 1610may be in communication with a health care provider 1615 to allow thehealth care provider 1615 to perform various modifications to theprogramming of the automated medication adherence system 1610 from aremote location. Additionally, this communication may alert a healthcare provider 1615 to problems, such as when the user 1605 fails toremove one or more dosages of medication from the pill delivery andlock-out module. Communication is preferably achieved by sending andreceiving medication events 1650 via a cloud application 1630.

Unless otherwise stated, all measurements, values, ratings, positions,magnitudes, sizes, locations, and other specifications that are setforth in this specification, including in the claims that follow, areapproximate, not exact. They are intended to have a reasonable rangethat is consistent with the functions to which they relate and with whatis customary in the art to which they pertain.

The foregoing description of the preferred embodiment has been presentedfor the purposes of illustration and description. While multipleembodiments are disclosed, still other embodiments will become apparentto those skilled in the art from the above detailed description. Thedisclosed embodiments capable of modifications in various obviousaspects, all without departing from the spirit and scope of theprotection. Accordingly, the detailed description is to be regarded asillustrative in nature and not restrictive. Also, although notexplicitly recited, one or more embodiments may be practiced incombination or conjunction with one another. Furthermore, the referenceor non-reference to a particular embodiment shall not be interpreted tolimit the scope. It is intended that the scope or protection not belimited by this detailed description, but by the claims and theequivalents to the claims that are appended hereto.

Unless otherwise stated, all measurements, values, ratings, positions,magnitudes, sizes, locations, and other specifications that are setforth in this specification, including in the claims that follow, areapproximate, not exact. They are intended to have a reasonable rangethat is consistent with the functions to which they relate and with whatis customary in the art to which they pertain.

The foregoing description of the preferred embodiment has been presentedfor the purposes of illustration and description. While multipleembodiments are disclosed, still other embodiments will become apparentto those skilled in the art from the above detailed description. Theseembodiments are capable of modifications in various obvious aspects, allwithout departing from the spirit and scope of protection. Accordingly,the detailed description is to be regarded as illustrative in nature andnot restrictive. Also, although not explicitly recited, one or moreembodiments may be practiced in combination or conjunction with oneanother. Furthermore, the reference or non-reference to a particularembodiment shall not be interpreted to limit the scope of protection. Itis intended that the scope of protection not be limited by this detaileddescription, but by the claims and the equivalents to the claims thatare appended hereto.

Except as stated immediately above, nothing that has been stated orillustrated is intended or should be interpreted to cause a dedicationof any component, step, feature, object, benefit, advantage, orequivalent, to the public, regardless of whether it is or is not recitedin the claims.

What is claimed is:
 1. An automated medication adherence system,comprising: a housing; an electronic interface; and one or more ofsensors; wherein said housing comprises a pill delivery and lock-outmodule; wherein said housing is configured to contain a plurality ofreservoirs; wherein said plurality of reservoirs are configured forreceiving, storing, and dispensing one or more medications; wherein saidhousing comprises an access cover; wherein said housing comprises areservoir loading door; wherein said access cover comprises a pillloading assembly; wherein said pill loading assembly is configured toallow said one or more medications to be loaded into at least one ofsaid plurality of reservoirs; wherein said reservoir loading doorcomprises a reservoir loading assembly; wherein said reservoir loadingdoor is configured to allow said one or more reservoirs to be loaded andlocked into a rotating carrier; wherein said electronic interfacecomprises a computing component and at least one display component;wherein said electronic interface is on an exterior portion of saidhousing; wherein said electronic interface is programmable, such thatsaid electronic interface accepts data relating to said one or moremedications; wherein each of said plurality of reservoirs is configuredto receive, store and dispense a homogenous type of medication of saidone or more medications; wherein each of said plurality of reservoirscomprises two successive stages, a first stage and a second stage;wherein said one or more medications are moved from said first stage tosaid second stage and then from said second stage to said pill deliveryand lock-out module; wherein said one or more medications are aplurality of pills; and wherein each of one or more sensors areconnected with said computing component; wherein said one or moresensors are configured to determine when a single pill of said pluralityof pills passes through each of said two successive stages.
 2. Theautomated medication adherence system of claim 1, further comprising: arotating carrier; wherein said rotating carrier is configured to engagewith said plurality of reservoirs, such that said plurality ofreservoirs are configured to rotate within said housing.
 3. Theautomated medication adherence system of claim 2, wherein saidelectronic interface rotates said plurality of reservoirs in response tosaid data relating to said one or more medications.
 4. The automatedmedication adherence system of claim 1, wherein said data relating tosaid one or more medications is selected from the group of dataconsisting of: a pill identity; a user identity; a dosage schedule; amedication format; a pill image; a plurality of pharmaceuticalindications for use; instructions for use; a physical description; achemical description; a refill information; and a plurality of sideeffect information.
 5. The automated medication adherence system ofclaim 1, wherein said two successive stages are configured to bestacked, such that said first stage is substantially above said secondstage; wherein each of said two successive stages comprises an opening,such that there are two openings, a first opening and a second opening.6. The automated medication adherence system of claim 5, wherein saidfirst opening and said second opening are selectively openable andclosable in response to said electronic interface; wherein each of saidtwo successive stages receive and dispense said one or more medicationsthrough said two openings.
 7. The automated medication adherence systemof claim 6, wherein each of said plurality of reservoirs comprises acentral agitation stalk, an outer wall; an inner wall; and one or moreactuators; wherein said central agitation stalk is configured to besubstantially contained within said inner wall, and wherein said innerwall is configured to be substantially contained within said outer wall;and wherein said central agitation stalk is configured to be rotatablewithin said inner wall.
 8. A medication reservoir for an automatedmedication adherence system, comprising: two successive stages, a firststage and a second stage; wherein said reservoir is configured forreceiving, storing, and dispensing a plurality of pills; whereindispensing of said plurality of pills by said reservoir is controlled byan electronic interface; wherein said plurality of pills are transferredfrom said first stage to said second stage one pill at a time; whereinsaid plurality of pills are transferred from said second stage to a pilldelivery and lock-out module one pill at a time.
 9. The medicationreservoir of claim 8, wherein each of said two successive stagescomprises an opening, such that there are two openings, a first openingand a second opening.
 10. The medication reservoir of claim 9, furthercomprising: one or more sensors; wherein said one or more sensors areconfigured to determine when a single pill of said plurality of pillspasses through each of said two openings.
 11. The medication reservoirof claim 10, wherein said first and second openings are selectivelyopenable and closable in response to said electronic interface; whereinsaid two successive stages are configured to be stacked, such that saidfirst stage is substantially above said second stage.
 12. The medicationreservoir of claim 11, wherein said reservoir further comprises acentral agitation stalk, an outer wall, an inner wall, and one or moreactuators; wherein said central agitation stalk is configured to besubstantially contained within said inner wall, and wherein said innerwall is configured to be substantially contained within said outer wall;and wherein said central agitation stalk is configured to be rotatablewithin said inner wall.
 13. The medication reservoir of claim 12,wherein said central agitation stalk comprises a fin portion, a wavesurface, and a ribbed cone surface; wherein said fin portion comprises aplurality of fins that are configured to prevent said one or moremedications from clumping together; wherein said wave surface is a baseof said first stage; and wherein said ribbed cone surface is a base ofsaid second stage.
 14. The medication reservoir of claim 13, whereinsaid one or more actuators are configured to rotate and agitate saidcentral agitation stalk and at least one of said inner wall and saidouter wall.
 15. The medication reservoir of claim 14, wherein said outerwall comprises one or more outer wall portholes and one or more chutes;wherein said inner wall comprises one or more inner wall portholes;wherein at least one of said one or more actuators is configured torotate at least one of said inner wall and said outer wall, such thatsaid inner wall and said outer wall are rotated with respect to eachother; wherein when said inner wall and said outer wall are rotated withrespect to each other, said one or more outer wall portholes and saidone or more inner wall portholes align to form said two openings;wherein said electronic interface comprises one or more logicalgorithms; wherein said one or more sensors, said one or moreactuators, and said one or more logic algorithms are configured tocontrol said inner wall, said outer wall, and said central agitationstalk to ensure that said one or more medications are transferred, onepill at a time, from said first stage to said second stage; and whereinsaid one or more sensors, said one or more actuators, and said one ormore logic algorithms are configured to control said inner wall, saidouter wall, and said central agitation stalk to ensure that said one ormore medications are transferred, one pill at a time, from said secondstage to said pill delivery and lock-out module.